Quality Assurance Lead

RXinsider LTD.; Knoxville, Northern (TN, KY); On-site; USD 75,000 - 90,000; Full time

Job summary

Galbraith Laboratories in Knoxville, TN is seeking a Quality Assurance Lead to oversee external representation, regulatory affairs, and CAPA systems within our Consumer Products Services division.

The ideal candidate holds a Bachelor's degree with 7+ years QA experience, strong regulatory knowledge (ISO 17025, GLP, GMP), and proven leadership to drive cross-functional quality initiatives in a fast-paced lab environment.

Qualifications

• Bachelor's degree with progressive QA responsibility
• Master's degree with QA progression
• Experience in regulatory audits and compliance management

Responsibilities

• Lead customer audits independently and support regulatory inspections
• Draft audit responses and corrective action plans
• Monitor regulation changes and close compliance gaps
• Oversee CAPA system and investigations
• Lead cross-departmental quality initiatives
• Report QA status to leadership and prepare Management Review materials
• Develop tracking and trending tools for quality metrics
• Collaborate with managers on quality policies and objectives
• Train QA team on data analysis and quality management

Skills

Leadership

Communication

Regulatory Expertise

Technical Proficiency

Education

Bachelor's Degree

Master's Degree

Tools

QMS software

Databases

Excel

Statistical tools

Windows

Job description

Overview

Business Title: Quality Assurance Lead
Position Title: Quality Assurance Specialist V
Division: Consumer Products Services
Entity: Galbraith Laboratories
Reports to: Sr Manager, QHSSE
FLSA: Exempt
Location: Knoxville, TN
Hours Worked: Typically, Monday through Friday, 40 per week
However, must be flexible to meet the needs of the department and complete other projects as assigned.

Major Roles & Responsibilities

External Representation & Regulatory Affairs

• Lead customer audits independently, and support QA Manager for regulatory inspections & agency visits
• Draft audit responses and corrective action plans
• Monitor regulation changes, assess risk, and close compliance gaps
• Assist with facilitating scope expansion with regulating/certifying bodies

Strategic Management

• Participate in cross-departmental corrective activities based on trends
• Support quality event trending and corrective actions
• Facilitate cross-departmental communication
• Improve efficiency and effectiveness of quality processes

Reporting & Oversight

• Assist in preparing Management Review Meeting reports
• Report quality systems status to QA Manager
• Develop tracking/trending tools and communicate trends to leadership
• Collaborate with managers on company policies, goals, and procedures

Advanced Technical Authority

• Oversee CAPA system
• Ensure departmental priorities, goals, and policies are met
• Oversee Quality Assurance Unit policies/procedures
• Approve/reject procedures and specifications for data/client reports
• Review and approve investigations, deviations, and change controls
• Direct inspections and audits for materials, facilities, and test results
• Advise Quality Manager on regulatory strategy and developments

Client Relations

• Resolve client issues to enhance satisfaction
• Lead client audits
• Track deviations, change controls, and complaints

Knowledge, Skills & Abilities

Core Competencies

• Leadership: Lead, develop, and motivate QA teams
• Communication: Exceptional written/verbal skills for executive reporting and stakeholder engagement
• Regulatory Expertise: Deep understanding of requirements and proactive compliance management
• Technical Proficiency: Advanced knowledge of QMS, statistical analysis, and validation

Technical Skills

• Expertise in QMS implementation and continuous improvement
• Thorough understanding of ISO 9001, 17025, CFR 210, 211, 820
• Proficient in quality data analysis, trending, and reporting
• Advanced proficiency with QMS software, databases, and statistical tools
• Expert knowledge of GLP, GMP, and regulatory frameworks

Management & Leadership

• Train and develop QA team on data analysis and quality management
• Strong interpersonal and relationship-building skills
• Oversee large, cross-departmental projects
• Excellent project management and coordination skills

Analytical & Problem-Solving

• Advanced problem-solving for complex quality challenges
• Manage multiple high-priority projects simultaneously
• Expertise in root cause analysis and corrective action implementation
• Strong attention to detail with strategic perspective

Additional Competencies

• Organizational and time management excellence
• Proactively interpret and apply new regulations
• Positive attitude, self-motivated, highly engaged
• Proficiency with Windows, Word, Excel, and specialized quality software

Required Qualifications

Experience & Educational Background

• Bachelor's Degree + 7 years QA experience with progressive responsibility

OR

• Master's Degree + 5 years QA experience with progressive responsibility

Preferred

• Laboratory/manufacturing quality management experience
• Regulatory inspection representation experience
• Multiple QMS experience (ISO 17025, ISO 9001, GLP, GMP)

Compensation

Compensation Range: $75,000 - $90,000 annually (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset)